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Clinical Trials List

Protocol NumberONO-4578-08
NCT Number(ClinicalTrials.gov Identfier)NCT06256328
Active

2023-10-05 - 2027-12-31

Phase II

Recruiting6

ICD-10C16.0

Malignant neoplasm of cardia

ICD-10C7A.092

Malignant carcinoid tumor of the stomach

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9151.0

Malignant neoplasm of cardia of stomach

A Randomized, Multicenter, Double-blind, Phase II Study to Compare the Efficacy and Safety of the Treatment With ONO-4578 in Combination With Nivolumab, Fluoropyrimidine-based and Platinum- Based Chemotherapy (Hereinafter Referred to as Chemotherapy) With Those of the Treatment With Placebo in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator I-CHEN WU Division of Hematology & Oncology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林建良 無
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Li-Yuan Bai Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Kun-Huei Yeh 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Shi Chen 無
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jui Yen Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Gastric Cancer

Objectives

main Evaluate the efficacy of the ONO-4578 group and compare it with the placebo group secondary Evaluate the efficacy of the ONO-4578 group and compare it with the placebo group Evaluating the safety of the ONO-4578 group compared with the placebo group exploratory Evaluating pharmacokinetics in participants in the ONO-4578 group Evaluate biomarkers

Test Drug

ONO-4578

Active Ingredient

ONO-4578
ONO-4578
ONO-4578

Dosage Form

tablet

Dosage

10mg
20mg
40mg

Endpoints

‧ Progression-free survival (PFS) (assessed by the trial moderator at the trial site)

Inclution Criteria

Inclusion Criteria:

Patients with gastric or esophagogastric junction cancer histologically diagnosed as adenocarcinoma
Patients have not been treated with systemic chemotherapy as first-line therapy
Patients who can provide tumor tissue samples

Exclusion Criteria

Exclusion Criteria:

Patients unable to take oral medicines
Patients with HER2-positive
Patients with contraindications to nivolumab, oxaliplatin, S-1, or capecitabine
Patients who have a history of severe drug-related adverse reactions caused by non- steroidal anti-inflammatory drugs (NSAIDs) or who have complications caused by NSAIDs requiring treatment
Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease, such as rheumatoid arthritis
Patients with headache and/or nausea associated with brain metastasis

The Estimated Number of Participants

  • Taiwan

    14 participants

  • Global

    210 participants

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